FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose
FDA Device · Class II · 2020-02-26 · Philips Medical Systems Dmc - Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or li…
FDA Device · Class II · 2020-02-26 · Covidien - Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by convert…
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
FDA Device · Class II · 2020-02-26 · Arrow International - Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
FDA Device · Class II · 2020-02-26 · Arrow International - 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
FDA Device · Class II · 2020-02-26 · Ethicon - LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg
FDA Device · Class I · 2020-02-26 · Philips Respironics - NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy pr…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
FDA Device · Class II · 2020-02-26 · Ethicon - Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting…
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection ha…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
FDA Device · Class II · 2020-02-26 · Arrow International - Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
FDA Device · Class II · 2020-02-26 · Arrow International - Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
FDA Device · Class II · 2020-02-26 · Arrow International - Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation…
FDA Device · Class II · 2020-02-26 · Covidien - Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting…
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
FDA Device · Class II · 2020-02-26 · Medicrea International - Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparin…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment scre…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Arrow EPIDURAL CATHETERIZATION KIT CK-02220
FDA Device · Class II · 2020-02-26 · Arrow International - (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ ST…
FDA Device · Class II · 2020-02-26 · Arrow International - Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
FDA Device · Class II · 2020-02-26 · Arrow International - Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at l…
FDA Device · Class I · 2020-02-26 · Philips Respironics - Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has b…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepar…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone
FDA Device · Class II · 2020-02-26 · Smith And Nephew - i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quant…
FDA Device · Class II · 2020-02-26 · Abbott Point - NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - TLC-2000 Therapeutic Medical Laser System
FDA Device · Class III · 2020-02-26 · Theralase - Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - PICC Set- PR-35052-HPHNM
FDA Device · Class II · 2020-02-26 · Arrow International - Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
FDA Device · Class II · 2020-02-26 · Covidien - Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepar…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or liga…
FDA Device · Class II · 2020-02-26 · Covidien - Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 1…
FDA Device · Class II · 2020-02-26 · Cardinal Health 200 - Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4…
FDA Device · Class II · 2020-02-26 · Teleflex Medical - NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea…
FDA Device · Class I · 2020-02-26 · Philips Respironics - OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
FDA Device · Class II · 2020-02-26 · The Binding Site Group - Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approxima…
FDA Device · Class II · 2020-02-26 · Covidien - Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
FDA Device · Class II · 2020-02-26 · Philips North America - Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA…
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
FDA Device · Class II · 2020-02-26 · Ormco Sybronendo - NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indi…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04
FDA Device · Class III · 2020-02-26 · Advanced Bionics - Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by convert…
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has be…
FDA Device · Class II · 2020-02-26 · Nobel Biocare Usa - NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or…
FDA Device · Class II · 2020-02-26 · Covidien - NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indi…
FDA Device · Class I · 2020-02-26 · Abbott Vascular - Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by convert…
FDA Device · Class II · 2020-02-26 · Siemens Medical Solutions Usa - TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain
FDA Device · Class III · 2020-02-26 · Theralase - FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code UR-05501
FDA Device · Class II · 2020-02-19 · Arrow International - VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600…
FDA Device · Class II · 2020-02-19 · Ortho Clinical Diagnostics - VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
FDA Device · Class II · 2020-02-19 · Biomerieux - Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. T…
FDA Device · Class II · 2020-02-19 · Microvention - FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
FDA Device · Class II · 2020-02-19 · Arrow International - Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to…
FDA Device · Class II · 2020-02-19 · Cardiac Assist - Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
FDA Device · Class I · 2020-02-19 · Medtronic - FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
FDA Device · Class II · 2020-02-19 · Arrow International - US Clinical 20mL Programmable Pump
FDA Device · Class II · 2020-02-19 · Flowonix Medical - Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
FDA Device · Class II · 2020-02-19 · Teleflex Medical - FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH
FDA Device · Class II · 2020-02-19 · Arrow International - Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-4…
FDA Device · Class II · 2020-02-19 · Microvention - Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part…
FDA Device · Class II · 2020-02-19 · Respironics California - Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
FDA Device · Class II · 2020-02-19 · Stryker - Prometra II 40mL Pump
FDA Device · Class II · 2020-02-19 · Flowonix Medical - Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Coro…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case,…
FDA Device · Class II · 2020-02-19 · Pacific Medical Group - FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
FDA Device · Class II · 2020-02-19 · Arrow International - EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
FDA Device · Class II · 2020-02-19 · Arrow International - FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
FDA Device · Class II · 2020-02-19 · Arrow International - Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2020-02-19 · Coopervision - Prometra II Programmable 20mL Pump
FDA Device · Class II · 2020-02-19 · Flowonix Medical
Other years
2026 (2,088) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)